FDA Device recall Z-1728-2013
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex
- FDA Device
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex by Karl Storz Endoscopy America, citing karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1728-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-31 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Karl Storz Endoscopy America |
| Distribution | AZ, FL, IL, IN, TX |
Product
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
Reason
Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.
Identifiers
| code_info | Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Karl Storz Endoscopy America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1728-2013%22
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